Impact of rituximab on the natural history of ITP [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Number of patients in complete response (platelet count>100G/L), in partial response (platelet count>50G/L and at least doubling the baseline platelet count)or in failure. Rate of diminution for the concomittant therapies for ITP.

Use of emergencies treatment for ITP.

Modality of the administration of rituximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]

number of perfusions, dosage, retreatment.

Characteristics of the patients receiving Rituximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]

age, sex, duration of ITP, previous used treatment

Evaluation of the Platelet count evolution [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.

Rate of splenectomy in the cohort [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:

250

Study Start Date:

April 2010

Estimated Study Completion Date:

April 2017

Estimated Primary Completion Date:

April 2012 (Final data collection date for primary outcome measure)

Detailed Description:

Rituximab (RTX) is used in the treatment of malignant non-Hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. Rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (RA) refractory to anti-TNF. To date, the RA is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. There are also data from the literature, for the benefit of rituximab in other autoimmune diseases like Lupus, cryoglobulinemia associated to Hepatitis C or Sjogren's disease.

Immune Thrombocytopenia (ITP) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. In adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. Rituximab was suggested during chronic ITP when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. These encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. In France, Afssaps - French Health Products Safety Agency has recently issued a temporary protocol processing to authorize rituximab in this indication. Nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. This justifies the creation of this register, whose establishment is recommended by Afssaps - French Health Products Safety Agency.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

Immune ThrombocytoPenia (ITP) patients according to the American Society of Hematology (ASH).

Criteria

Inclusion Criteria:

ITP diagnosis according to the American Society of Hematology society

Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01101295